Kornimate/medical-research-clean huggingface dataset:
prevalence of antibodies to selected porcine viruses in patients with cystic fibrosis receiving porcine-derived pancreatic enzyme replacement therapy

Conditions: Cystic Fibrosis

Summary: this is a point prevalence study conducted entirely in the united states (us) to establish the prevalence of antibodies to hepatitis e virus (hev) and other selected porcine viruses in cystic fibrosis (cf) patients receiving pancreatic enzyme replacement therapy (pert) for pancreatic insufficiency compared with matched (age and region of residence) control patients with chronic medical conditions unexposed to pert.

this is a multicenter, non-interventional point-prevalence study conducted in the us to determine the seroprevalence of antibodies to selected porcine viruses in pancreatic enzyme replacement therapy-exposed cf patients and in an unexposed control group with chronic medical conditions matched for age and geographic region of residence. data collection includes demographic and medical history, pancreatic enzyme replacement therapy, transfusion history, and history of potential exposure to pig viruses. if a patient meets all the requirements of the study and provides a study specific informed consent/assent, a single blood sample is obtained as part of a planned standard-of-care blood collection. this harmonized protocol reflects equal sponsorship not only by the registering sponsor, abbvie, but also the collaborators, aptalis pharma and janssen research \& development, llc.

Eligibility criteria:
inclusion criteria: all patients (pert-exposed and unexposed controls) must meet the following criteria: * have a blood draw planned as part of their standard of care following enrollment into the study; and * provide informed consent/assent. patients in the pert-exposed group must meet the following criteria: * have been diagnosed with cf; and * have received pert for a minimum of 6 months. patients in the unexposed control group must meet the following criteria: * be under medical management for chronic disease; * never received any pert product; and * match an enrolled pert-exposed patient based on age and region-of-residence. * have a blood draw planned to be performed within 180 days of the matched pert-exposed patient blood draw. exclusion criteria: * has a porcine heart valve, a porcine-derived graft, or has had exposure to porcine derived insulin. this exclusion does not apply to previous porcine-derived heparin exposure. ; * refuses blood collection; or * has any condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments.

Keywords: pancreatic enzyme replacement therapy antibodies porcine viruses epidemiology prospective
bisphosphonate therapy for osteogenesis imperfecta

Conditions: Osteogenesis Imperfecta; Osteoporosis; Paget Disease of Bone

Summary: the study is designed to evaluate the efficacy and safety of "bisphosphonate therapy for osteogenesis imperfecta (oi)." we, the researchers at indiana university school of medicine, are characterizing the changes effected by oral bisphosphonate therapy and comparing them to a regimen of intravenous bisphosphonate therapy in a group of children with oi and also in children with other disorders that result in low bone mass and fractures.

the study is designed to evaluate the efficacy and safety of "bisphosphonate therapy for osteogenesis imperfecta (oi)." oi is an inherited disorder of collagen synthesis. collagen is the major structural protein of the matrix of tendons, skin, and bones. affected persons have low bone mineral density (and experience multiple fractures and progressive bony deformity). in its most severe form, the disorder is lethal in infancy. we plan to characterize the changes effected by oral bisphosphonate therapy and compare them to a regimen of intravenous bisphosphonate therapy in a group of children with oi. additionally, we have begun to treat patients with oi and other conditions of low bone mineralization for age who are not eligible for the standard protocol (too young, history of abdominal pain, etc.) with bisphosphonate. we also plan to screen the parents and siblings of our patients diagnosed with osteogenesis imperfecta, in order to determine if they also have osteoporosis.

Eligibility criteria:
inclusion criteria: * diagnosis of oi, as defined by genetic analysis revealing a defect of type i collagen, or by bone mineral density (bmd) \<2.5 standard deviations (sd) for age plus two of the following: * family history of oi * frequent fractures * blue sclerae * multiple wormian bones on skull x-ray * hearing disturbance * dentinogenesis imperfecta * age between 3 and 21 years at the start of the study period. * children must be able to swallow whole tablets * parents of children must be able to understand protocol and give informed consent. exclusion criteria: * therapy with bisphosphonates during the past 12 months. * other "non-traditional" therapy for oi in the last 6 months, such as growth hormone or anabolic steroids. * other chronic diseases besides oi that interfere with bone morphology or gastrointestinal absorption

Keywords: osteogenesis imperfecta fractures pediatric osteoporosis juvenile pagets
consistency study for three commercial lots of inactivated poliomyelitis vaccine made from sabin strain

Conditions: Poliomyelitis

Summary: a randomized and blind clinical consistency study for three commercial batches of inactivated poliomyelitis vaccine made from sabin strain (sipv) for immunogenicity and safety evaluation.

this randomized and blind clinical study includes three test groups with 400 infants for each group. sample estimation for this study has been conducted using statistical methods. a total of 1,200 2-month old healthy subjects were enrolled for inoculation of vaccine from 3 different lots with 1 month interval. all subjects received blood collection for immunogenicity test before and after primary immunization for evaluation of immunogenicity consistency, while safety observation was conducted within 30 days after each vaccination (30min via close safety monitoring, 0-7 days via participant diary card and 8-30 days via contact card for collection of adverse events) for safety evaluation of sipv of 3 commercial lots.

Eligibility criteria:
inclusion criteria: * healthy infants of 2 months of age * the legal identity certificate (birth/household register) and vaccination certificate of the participants can be provided, and the legal guardian can provide the legal identity certificate (identity card). * guardians are able to understand the experimental vaccine, volunteer to participate in the study and sign informed consent for participation. * guardians are capable of using thermometer, graduated scale, filling diary card and contact card. * participants are not vaccinated with polio vaccine and immunoglobulin (except for hepatitis b specific immunoglobulin) after birth, no vaccination of live vaccine within 28 days before enrollment and no vaccination of inactivated vaccine within 14 days before enrollment. * participants or guardians are able to obey and follow all study instructions, complete all the monitoring, and cooperate to complete collection of blood sample. * axillary temperature ≤37℃ exclusion criteria: * allergic to any active substance, inactive substance or materials used during production such as kanamycin. * patients with fever or acute disease. * have thrombocytopenia or hemorrhagic diseases * patients undergoing immunosuppressive therapy or immunodeficiency * have uncontrolled epilepsy or other progressive neurological disorders * other situations that the investigator consider as non-eligible
efficacy and safety of bct197 in subjects with acute respiratory exacerbations of chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is to compare the efficacy and safety of bct197 when added on to standard of care in adult subjects with acute respiratory exacerbations of chronic obstructive pulmonary disease requiring hospitalization. additionally, the study will characterize the pharmacokinetics of bct197 in adults with copd. the total duration of the study will be 26 weeks. subjects will receive study treatment administration over a period of 5 days after randomization. it is expected that approximately 255 subjects will complete the study and follow-up.


Eligibility criteria:
inclusion criteria: * male and female adults * presence of an active exacerbation of the ongoing copd requiring hospitalization for treatment * subjects with a documented diagnosis of copd c or d * current smokers or ex-smokers * a documented history of at least one moderate or severe copd exacerbation in the 12 months preceding the screening visit that required antibiotics and/or systemic corticosteroid. * current regular treatment for copd (for at least 2 months prior to the screening visit. exclusion criteria: * age less than 40 years old * current diagnosis of asthma * subjects who have already completed treatment for the current exacerbation of copd * subjects currently requiring intensive care unit (icu) and/or mechanical ventilation * received a course of pde4, p38 or pde3/4 inhibitors within their respective defined washout periods.
stroke research initiative to advance equity

Conditions: Stroke

Summary: 1. assess patient-centered outcomes (pcos) amongst stroke survivors and their caregivers in the medstar health system longitudinally. i. utilize a community advisory board (cab) of stroke survivors and their caregivers to identify the patient-centered outcome(s) that they determine to be most important and valuable to assess based on their lived experiences. ii. collect the chosen pcos at multiple time points using an electronic survey tool (e.g. qualtrics, tonic or redcap) 2. evaluate the impact of social determinants of health (sdoh) and experiences of discrimination on the chosen pcos. 3. examine whether there are differences in long-term pcos amongst stroke survivors from different racial and ethnic groups. 2.2 hypothesis: we hypothesize that stroke survivors that come from historically marginalized populations, specifically african american and latinos, will have lower patient-centered outcome scores overall as compared to their caucasian counterparts. in addition, we hypothesize that the difference pco scores between caucasian and african american and latino populations will be due in part to experienced discrimination and not sdoh alone. .


Eligibility criteria:
stroke survivor: inclusion criteria: ≥ 18 years old acute ischemic stroke (ais) or intracerebral hemorrhage (ich) patients that have been cared for in the medstar healthcare system ais of ich in the last six weeks ability to communicate in english, spanish, amharic, mandarin chinese or french (most common languages in the greater washington, dc area) exclusion criteria: transient ischemic attack (tia) or subarachnoid hemorrhage (sah) unable to complete required forms life expectancy less than 6 months caregiver inclusion criteria age ≥ 18 self-identify as primary caregiver for the stroke survivor ability to communicate in english, spanish, amharic, mandarin chinese, french exclusion criteria unable to complete study survey forms life expectancy less than 6 months
ropivacaine volume for ultrasound-guided retrograde infraclavicular brachial plexus block

Conditions: Upper Extremity Injury Trauma

Summary: the retrograde infraclavicular brachial plexus block has been proved an effective and safe approach. realtime ultrasound guide will facilitate a successful peripheral nerve block. the purpose of this study was to determine the medium effective volume required to produce an effective retrograde infraclavicular block using an ultrasound (us)-guided technique.

thirty adults undergoing elective upper limb surgery received an us-guided retrograde infraclavicular block. the initial concentration of 0.5% ropivacaine injected was 30 ml, which was subsequently varied at a ratio of 1: 1.2 for each consecutive patient according to the response of the previous patient. the medium effective volume (ev50) was determined using the dixon and massey up-and-down method. the effective volume in 95% of patients (ev95) was calculated using probit regression.

Eligibility criteria:
inclusion criteria: * elected upper extremity operations * bmi 17\~30kg/m2 * asa i/ii exclusion criteria: * infection at injection site * sepsis * coagulation dysfunction * phrenic nerve palsy * pneumothorax * recurrent laryngeal nerve palsy * clavicle fracture combined with nerve damage

Keywords: anesthetic techniques,regional drug delivery,volume anesthetic, local: ropivacaine
identifying the optimal dynamic ankle-foot orthosis bending stiffness for individuals post-stroke

Conditions: Stroke

Summary: ankle braces are commonly prescribed to individuals who have suffered a stroke to help their ankle joints work properly, which allows these individuals to walk better. currently, there are no standardized guidelines to follow when choosing which brace is best for an individual. prior work has shown that customizing the level of assistance that these braces provide based on each individual's level of ankle impairment improves the individuals' walking function more than their current brace. the next important step is to fine-tune the customization and work to develop a set of guidelines that can be used by clinicians to help them prescribe the right brace for each patient's needs. the purpose of this study is to test different levels of assistance provided by the brace to determine the optimal customization method. additionally, this study aims to begin to create a guide to help clinicians choose the best brace for each individuals' needs. to accomplish this goal, individuals will walk with a brace under five different assistance level conditions. the individual's walking function, performance on clinical measures, and response to questionnaires will be examined to determine both the optimal brace for each individual and hopefully identify clinical tools that can be used to guide prescription of the brace. this study is a major step towards developing effective, standardized prescription guidelines that optimize walking of individuals post-stroke.


Eligibility criteria:
inclusion criteria: * chronic stroke (\> 6 months post-stroke) * been prescribed an afo by a clinician * have plantar flexor strength deficits (unable to complete at least 25 standing heel-raises * have at least 5 degrees of passive dorsiflexion range of motion (as measured during the clinical evaluation in visit 1). exclusion criteria: * those that will not be included in this study are individuals with 1) evidence of cerebellar stroke on clinical mri, 2) other neurologic conditions in addition to stroke, 3) sensorimotor neglect, 4) inability to walk outside the home prior to the stroke, 5) total joint replacement or orthopedic problems in the lower limbs or spine that limit walking, 6) coronary artery bypass graft or myocardial infarction within past 3 months, 7) unexplained dizziness in last 6 months, 8) inability to communicate with investigators, 9) lack of decisional capacity.

Keywords: ankle-foot orthosis
prediction for bronchopulmonary dysplasia

Conditions: Bronchopulmonary Dysplasia

Summary: in this multi-center study performed from january 2018, we reviewed data on infants whose gestational ages were below 36 weeks. we collected data containing maternal diseases and neonatal clinical features. lasso regression was used to select variables for the risk model. then, we used multivariable logistic regression to build the prediction model incorporating these selected features. discrimination was assessed by the c-index, and and calibration of the model was assessed by and calibration curve and the hosmer-lemeshow test.


Eligibility criteria:
inclusion criteria: * patients were recruited from multi-center collaborative group hospital neonatal intensive care unit (nicu) department. * patients with gestational age \<36 weeks * admitted to the nicu within 24 h after birth * the length of stay was more than 1 week exclusion criteria: * patients with inherited disease, metabolic disorders and multiple malformations.

Keywords: bronchopulmonary dysplasia; infants；nomogram
molecular determinants of persistent cancer related fatigue

Conditions: Fatigue; Pain; Poor Sleep Quality

Summary: the purpose of this study is to determine if inflammatory markers in blood as well as brain neurotransmitters (markers of in-brain activity and metabolism) are related to long-term or chronic fatigue.


Eligibility criteria:
inclusion criteria: all participants: - women age 18 or older with no contraindication to magnetic resonance imaging(mri); fatigued bc participants: * have a diagnosis of breast cancer; * and have completed all cancer-related treatments (i.e., surgery, chemotherapy, radiotherapy, immunotherapy, etc.) except for hormonal therapy and or herceptin at least 12 weeks previously; and be apparently cancer-free. age-matched, healthy participants: * generally healthy; * matched in age ± 2.5 years to a fatigued bc participant. * no prior history of any cancer except for basal cell or squamous cell tumors of the skin that have been surgically excised; * have good sleep quality * have no chronic pain * have no chronic fatigue exclusion criteria: * pregnant, wanting to become pregnant or lactating women ; * diagnosed with anemia \[defined as hemoglobin levels \< 12 gm/dl\] or receiving treatment for anemia ; * diagnosed with any comorbidities likely to cause significant fatigue (i.e., moderate to severe heart failure) * diagnosed with nutritional deficiencies; * have a diagnosis of untreated hypo- or hyper-thyroidism * have an initiation, a cessation or change of dose (up to three weeks prior to the study's start) of any chronic medications or dietary supplements or any planned change of chronic medications or dietary supplements during the study; * have implanted (e.g., surgical clips or staples) metal objects.
the physiological effects of acute and ramp simulated altitude exposure during simulated flight tasks

Conditions: Altitude Hypoxia

Summary: • the purpose of this study is to investigate which physiological process that controls normal human body homeostasis is affected by low levels of acute hypoxic exposure and whether there is a difference in those physiological processes and simulated flight performance between a rapid and ramp hypoxic exposure. to accomplish this, pilot analogs will be exposed to normoxic, simulated 8,000 ft (2438 m), simulated 12,000 ft (3658 m), and a ramp exposure breathing at simulated 8,000 ft for 5 minutes before ascending to simulated 12,000 ft while flying in a flight simulator. during the flight simulator, participants will need to accomplish three tasks: 1) maintaining an altitude of 5,000 ft of elevation while performing a mental math test, 2) flying the aircraft through the center of a series of 7 targets, and 3) taking off and flying the aircraft a short distance to land on the center of an indicated target. physiological measures of heart rate variability (hrv), blood pressure (bp), peripheral oxygen saturation (spo2), electrodermal activity (eda), and neck neuromuscular activity using electromyography (emg) will be measured for this study. along with questionnaires to assess hypoxic symptoms, simulator sickness, and self-perceived workload for each task


Eligibility criteria:
inclusion criteria: * meets body composition standards for the us navy active-duty personnel based on height and weight * normal vision/corrected to normal vision exclusion criteria: * respiratory deficiencies * cardiovascular disorders * neurological/musculoskeletal disorders * photosensitive epilepsy
chest physiotherapy in bronchiolitis

Conditions: Bronchiolitis

Summary: randomized trial of chest physiotherapy in outpatients with bronchiolitis under two years of age, during two consecutive seasonal outbreaks.

a randomized controlled trial was conducted (following consort statement) in the paediatric emergency department of centro hospitalar universitário são joão-porto (chusj), a tertiary care hospital, during the period from december to march in 2011 and 2012. ethical approval was obtained from the ethics committee of centro hospitalar universitário são joão-porto. children up to 2 years of age, both genders, with a diagnosis of acute bronchiolitis based on clinical findings, including wheezing or wheezing with crackles, respiratory distress and alteration of feeding condition, were signalized by the physician who met them at the emergency room. then, the main investigator of the study interviewed the caregivers and informed about the aims and procedures of the study, after a formal written consent in accordance with the declaration of helsinki was sign by all the caregivers. severity grade was established with the kristjansson respiratory score which variate from light to severe, being the light to moderate selected to study. randomization in intervention or control group was made by the method of permuted-blocks. all children were assessed in a calm environment, while awake and not crying, and were submitted to a standard assessment protocol consisting of a clinical demographic data collection by interview of parents and the application of the kristjansson respiratory score. all children underwent the same medical treatment protocol at the pediatric emergency department (ped), consisting in nebulization with medication, during the emergency room episode, and counselled in the subsequent one or two weeks and were followed during two weeks after discharge from ped, being reassessed at the end of the two weeks. children from intervention group (ig) underwent a standard intervention chest physiotherapy protocol performed by a physiotherapist, consisting on the techniques: prolonged slow expiration (pse), rhinopharyngeal retrograde clearance (rrc) and provoked cough (pc).

Eligibility criteria:
inclusion criteria: * children up to 2 years of age, both genders, with a diagnosis of acute bronchiolitis exclusion criteria: * presence of comorbidities, such as cystic fibrosis, neuromuscular, congenital heart disease, prematurity or respiratory distress and all the cases that were admitted into the hospital

Keywords: bronchiolitis chest physiotherapy children
radotinib as 3rd or later line therapy in cp-cml

Conditions: Chronic Myeloid Leukemia

Summary: the purpose of this study is to determine whether radotinib is effective and safe for patients with chronic myeloid leukemia, chronic phase who are intolerable or resistant to prior 2 or more tyrosine kinase inhibitors.

the purpose of this study is to determine whether radotinib 400mg bid is effective and safe for patients with chronic myeloid leukemia, chronic phase who are intolerable or resistant to prior 2 or more tyrosine kinase inhibitors. the primary end point is major cytogenetic response by 12 months.

Eligibility criteria:
inclusion criteria: * chronic myeloid leukemia chronic phase (cp-cml) patients who are not tolerable or resistant to prior 2 or more tyrosine kinase inhibitors (tkis). * ecog 0, 1, 2 * patients who are agree and signed to informed consent. exclusion criteria: * t315i mutation * prior exposure to radotinib * accelerated or blastic phase * galactose intolerance, severe lactase deficiency or glucose galactose malabsorption * prior history of intensive cytotoxic chemotherapy except for tkis * significant cardiac problem * qtcf \> 450 msec * pancreatitis history prior to study enrollment * clinically significant malignant disease other than cml * pregnant or breast feeding woman

Keywords: chronic myeloid leukemia intolerance resitance radotinib